Particle deflection pad and method of use

ABSTRACT

A device and a method of making and using the device for preventing sedimentation of airborne particles on a surface. The device includes a pad comprising with top surface, where openings are formed in the top surface, where a plurality of nozzle is situated in the openings such that a portion of the nozzle is an outlet for directing a stream of gas in an essentially perpendicular direction away from the top surface. The device also includes a hose connected to the nozzle such that the hose supplies the nozzles in the pad with the gas and a conditioning source that brings the gas into the hose after cleaning it. The flow requirements are automatically adjusted by the system (e.g., based on characteristics of the particle load).

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.62/337,049 filed May 16, 2016, entitled, “PARTICLE DEFLECTION PAD ANDMETHOD OF USE” and International Application No. PCT/US17/32695, filedMay 15, 2017, entitled “PARTICLE DEFLECTION PAD AND METHOD OF USE” whichis incorporated herein by reference in its entirety.

FIELD OF INVENTION

This invention relates to air quality control, and more particularly, topreventing the sedimentation of airborne small particles on surfaces.

BACKGROUND OF INVENTION

When airborne particulate matter settles on formerly clean and sterilesurfaces, the particulate matter introduces certain risks in proceduresthat rely upon those surfaces remaining clean and sterile, e.g.,surgical procedures, laboratory processes, food preparation and/ormanufacturing processes. In surgical procedures, an accumulation ofparticulate matter on surfaces introduces a risk of infection to apatient and in laboratory and manufacturing processes, this accumulationcan become a contaminant.

SUMMARY OF INVENTION

Shortcomings of the prior art are also overcome and additionaladvantages are provided through the provision of a device for preventingsedimentation of airborne particles on a surface, the device comprising:a pad comprising a top surface, wherein one or more openings are formedin the top surface, wherein nozzles are situated in the openings suchthat a portion of each nozzle is an outlet for directing a Jetstream ofgas in essentially a perpendicular direction away from the top surfaceof said pad; and a hose connected to the nozzle such that the hosesupplies the pad with the gas; a conditioning source that brings the gasinto the hose after cleaning it.

Shortcomings of the prior art are also overcome and additionaladvantages are provided through the provision of a device for preventingsedimentation of airborne particles on a surface, the device comprising:a pad comprising: a sheet of flexible material comprising a top surfaceand a bottom surface and an area in-between, the top surface comprisinga hole; a gas-flow directing channel formed in a portion of the area ona horizontal plane parallel to the top surface, wherein the gas-flowdirecting channel accommodates gas moving through the gas-flow directingchannel, wherein the gas-flow directing channel is defined by acylindrical channel in the flexible material in the portion of the area;an opening formed in the flexible material defining the gas-flowdirecting channel, the opening situated adjacent to the hole; a nozzleformed in the opening and in the hole, wherein the nozzle directs thegas from the gas-flow directing channel in a direction predominantlyperpendicular to the top surface of the pad, to prevent sedimentation ofairborne particles on the top surface; and an inlet in a second portionof the area to accommodate a hose, wherein attaching the hose to theinlet provides the gas to the gas-flow directing channel in the pad.

Shortcomings of the prior art are also overcome and additionaladvantages are provided through the provision of a device for preventingsedimentation of airborne particles on a surface, the device comprising:a pad comprised of a flexible material with a top surface and a bottomsurface and two side surfaces, wherein the top surface is parallel tothe bottom surface, the top surface comprising a plurality of openings,wherein each opening terminates at location in a channel formed in theflexible material between the top surface and the bottom surface,wherein the pad further comprises an inlet in a side surface, the inletconfigured to accept a hose; and a plurality of nozzles, wherein eachnozzle is formed in an opening of the plurality of openings.

Shortcomings of the prior art are also overcome and additionaladvantages are provided through the provision of a method for preventingsedimentation of airborne particles on a surface, the method comprising:placing a pad on the surface, the pad comprising a top surface, whereina plurality of openings is formed in the top surface, wherein nozzlesare situated in the openings such that a portion of each nozzle is anoutlet for directing a channel of gas in an essentially perpendiculardirection away from the top surface; and a hose connected to the padsuch that the hose supplies the nozzles with the gas; a conditioningsource that brings the gas into the hose after cleaning it andconditioning its temperature, humidity and/or electrical charge (e.g.ionization); and conducting an activity in a vicinity of the pad whereinthe surface remains particle-free and/or sterile.

Shortcomings of the prior art are also overcome and additionaladvantages are provided through the provision of a method for preventingsedimentation of airborne particles on a surface, the method comprising:placing a pad on the surface, the pad comprising: a sheet of flexiblematerial comprising a top surface and a bottom surface and an areain-between, the top surface comprising a hole; a gas-flow directingchannel formed in a portion of the area on a horizontal plane parallelto the top surface, wherein the gas-flow directing channel accommodatesgas moving through the gas-flow directing channel, wherein the gas-flowdirecting channel is defined by a cylindrical channel in the flexiblematerial in the portion of the area; an opening formed in the flexiblematerial defining the gas-flow directing channel, the opening situatedadjacent to the hole; a nozzle formed in the opening and in the hole,wherein the nozzle directs the gas from the gas-flow directing channelin a direction predominantly perpendicular to the top surface of thepad, to prevent sedimentation of airborne particles on the top surface;and an inlet in a second portion of the area to accommodate a hose,wherein attaching the hose to the inlet provides the gas to the gas-flowdirecting channel in the pad; coupling a hose to the inlet, wherein thehose is coupled to a conditioning source, wherein the conditioningsource provides gas to the hose; and conducting an activity in avicinity of the pad, wherein the surface remains sterile.

Additional features are realized through the techniques of the presentinvention. Other embodiments and aspects of the invention are describedin detail herein and are considered a part of the claimed invention.

BRIEF DESCRIPTION OF DRAWINGS

One or more aspects of the present invention are particularly pointedout and distinctly claimed as examples in the claims at the conclusionof the specification. The foregoing and objects, features, andadvantages of one or more aspects of the invention are apparent from thefollowing detailed description taken in conjunction with theaccompanying drawing.

FIG. 1 depicts the relationships between the water particlesgravitational settling velocity and the diameter of the particles inmicron.

FIG. 2 is a schematic view of an operating theatre utilizing a prior artlaminar flow system and streamlines of air flow around objects.

FIG. 3 is a schematic view of an operation with side blowing air flowdevice and streamlines of direct and entrained flows where a prior artmethod of particle mitigation is utilized.

FIG. 4 is a schematic view of a prior art horizontal local nozzle flowdevice and streamlines of the air interacting with objects in thesurgical field.

FIG. 5 is a top view of certain aspects of an embodiment of the presentinvention.

FIG. 6 is a side view of certain aspects of an embodiment of the presentinvention.

FIG. 7 is a top view of certain aspects of an embodiment of the presentinvention.

FIG. 8 depicts aspects of an embodiment of the present invention as itmay be utilized in an operating room scenario.

FIG. 9 is an isometric view of aspects of an embodiment of the presentinvention when utilized in conjunction with a procedure performed on theleg of a patient.

FIG. 10 is an isometric view of aspects of an embodiment of the presentinvention when utilized in conjunction with a procedure performed on thearm of a patient.

FIG. 11A is a top view of certain aspects of an embodiment of thepresent invention.

FIG. 11B is an isometric view of certain aspects of an embodiment of thepresent invention.

FIG. 12 depicts aspects of an embodiment of the present invention as itmay be utilized on an instruments table.

FIG. 13A is a cut view of certain aspects of an embodiment of thepresent invention.

FIG. 13B is an isometric view of certain aspects of an embodiment of thepresent invention.

FIG. 13C is a cut view of certain aspects of an embodiment of thepresent invention.

FIG. 14A is a cut view of certain aspects of an embodiment of thepresent invention.

FIG. 14B is an isometric view of certain aspects of an embodiment of thepresent invention.

FIG. 15 is workflow illustrating certain aspects of some embodiments ofthe present invention.

FIG. 16 is an illustration of certain aspects of some embodiments of thepresent invention.

DETAILED DESCRIPTION OF THE INVENTION

Aspects of the present invention and certain features, advantages, anddetails thereof, are explained more fully below with reference to thenon-limiting examples illustrated in the accompanying drawings.Descriptions of well-known materials, fabrication tools, processingtechniques, etc., are omitted so as not to unnecessarily obscure theinvention in detail. It should be understood, however, that the detaileddescription and the specific examples, while indicating aspects of theinvention, are given by way of illustration only, and not by way oflimitation. Various substitutions, modifications, additions, and/orarrangements, within the spirit and/or scope of the underlying inventiveconcepts will be apparent to those skilled in the art from thisdisclosure.

Embodiments of the present invention include both an apparatus and amethod for deflecting small airborne particulate matter from a surfaceand preventing this matter from coming into contact with the surface. Asunderstood by one of skill in the art, this matter may include bothinfective and/or toxic particles. To this end, in an embodiment of thepresent invention, a pad (which may also be understood as a flexiblesheet) is placed beneath or on a given surface and this pad generates anessentially perpendicular flow of highly purified air in multiplecontrolled streams aimed to engulf the surface and to prevent any smallparticles from coming into contact with the surface. In one aspect ofcertain embodiments of the present invention, during a surgicalprocedure, this flow-emitting sheet is placed beneath a body part and/ora tray of surgical instruments. The flow-emitting sheet placementreduces the risk of infection by keeping the surface sterile (e.g.,particle-free). Embodiments of the present invention can also beutilized to maintain particles-free sterile surfaces for electronicassembly production, food preparations, and/or in bacteriologylaboratories.

Embodiments of the present invention differ from, and presentimprovements over, current methods of maintaining the sterility ofsurfaces in a given environment. These current methods involve blowinglarge amounts of filtered air towards the surfaces in a perpendicular ortangential direction. This flow of filtered air is meant to preventunfiltered air carrying airborne contaminants from coming into contactwith the surfaces and is achieved by blowing air directly towards thesurface either from above, for example, as in vertically directed“laminar flow” rooms and hoods, or horizontally in parallel to thesurface.

Despite the use of these current methods, surgical site infection (SSI)remains a major risk in surgical procedures. Many SSI cases originate bybeing infected by common skin and fecal bacteria such as staphylococcusaureus, coagulase-negative staphylococci, Enterococcus spp. andEscherichia coli. Given the continued prevalence of these types ofinfection, the effectiveness of laminar flow systems in preventing SSIhas been questioned because in recent years due to the concern thatelements residing in the path of the flow such as the surgical lamp andeven the surgeons themselves could be creating secondary flows therebyintroducing contaminants into the surgical environment. However,building operating rooms (ORO with advanced air handling systemsprovides only marginal benefits. Extensive flow-analysis modeling hasrevealed the extent of these uncontrolled secondary flows.

The difficulties with existing devices and methods are tied both totheir poor efficacy and their very large price tag. Despite the lack ofsuccess in reducing SSI by these devices, cost in excess of five hundredthousand US dollars ($500,000) to install and then thousands to operate(e.g., electricity, filters) over more than thirty (30) years. With thenotion that even a single bacteria landing on or near an implant cancause a surgical site infection, these results clearly leave room forimprovements.

Embodiments of the present invention address a process flaw in existingdevices: they blow air onto the surface that needs to be maintainedclean and sterile rather than away from it. As a result, any particlesthat manage to be swept by the flow (e.g., through secondary eddies,and/or due to entrainment of side streams by the flow of gas out of thehorizontal devices described above, etc.) are carried directly andforcefully onto the surface that is to be maintained clean and free ofcontamination. In contrast, embodiments of the present invention blowair away from the sterile and clean surface in order to maintain thesterility and cleanliness of this surface.

Embodiments of the present invention include a pad that generates a flowof highly purified air in multiple controlled streams aimed to engulfthe surface and to prevent any small particles from coming into contactwith the surface. In an embodiment of the present invention, correctpump capacity and flow requirements can be automatically adjusted by thesystem (e.g., based on characteristics of the particle load) and/or canbe selected and set for any size pad surface. FIG. 1 demonstrates therelationships between the water particles gravitational settlingvelocity and the diameter of the particles in micron The settling orsedimentation velocity of a particle in air (u) is determined by theparticle radius (r) and shape, the densities of the particle (ρ_(P)) andthe surrounding air (ρ_(A)) and by the viscosity of the air (μ□□ so thatin low Reynolds Numbers (Re) the settling velocity is given by Equation1, the Stokes drag equation.

U _(z) =g(ρ_(P)−ρ_(A))d ²/18μ  (Equation 1)

Above, g is the gravitational acceleration. For a water particle of 1micron (10′ meter) diameter the velocity is given by: 9.8 m/s²*(1000−1.2kg/cm³)*10⁻¹² m²/(1.78×10⁻⁵ kg/(m s))=0.00003 m/s or 0.003 cm/s while a10 micron particle will settle at a velocity of 0.003 m/s or 0.3 cm/s. A30 micron water particle will settle at 2.7 cm/s. The typical size ofexpiratory droplets that contain bacteria is 1-10 micrometer.

In order to illustrate the differences between embodiments of thepresent invention and current methods for mitigating sedimentation ofairborne particles on surfaces maintained as sterile, FIGS. 2-4 depictexamples of these current methods and FIGS. 5-16 illustrate aspects ofcertain embodiments of the present invention. Turning first to FIGS.2-4, as aforementioned, embodiments of the present invention can beutilized in many different environments that benefit from themaintenance of sterile surfaces. However, a surgical environments isselected in FIGS. 2-4 to illustrate shortcomings of existing methodsthat are overcome by aspects of certain embodiments of the presentinvention.

FIG. 2 is a schematic of a roof emitted laminar flow method where anessentially non-turbulent flow of cleaned air is blown from adistributed array 10 at the top of a room. The streamlines of theairflow are shown as dashed lines 12 within a region often bounded by aframe 14 whose cut section is schematically shown. When the essentiallylaminar flow of air hits objects in its field such as the surgeon 20 andother staff members, the patient 22, the surgical tools preparationtable 18, or the operating table 26, the flow is diverted and reflectedso that large and small turbulent eddies 16 are formed and the flow isno longer laminar. In fact, as illustrated in FIG. 2, the flow steamlines may change direction so that they can pick up non-sterileparticles from the floor and other non-sterile elements in the room andbring them up to eventually get deposited onto the surgical field. Thismay result in contamination of the incision which may lead to a SSI.

FIG. 3 is a schematic drawings depicting another category of surgicalclean air emitter, a sideward laminar flow blower. As seen in FIG. 3,the clean-air blower 40 is placed on a movable stand 42 near the patient44 and the operating table 46 to direct a stream of air towards thesurgical site. A shortcoming of this method is illustrated by FIG. 3:the surgeon 48 and assistant 50 work in the flow field and can createdisturbances and turbulent eddies as shown in FIG. 3. In addition, anair blower that intends to focus directional airflow 54 in any specificdirection also entrains air from around the blower 52 by virtue of theBernoulli Effect. This entrained air 52 is not filtered and containsparticles and bacteria thereby defeating the purpose of the use of theillustrated device and method.

FIG. 4 depicts a current method where a local source of airflow 70 isplaced in or very near the surgical field. The air flow source 70 issupplied with cleaned air via a hose 72 from a pump (not shown). Theairflow source 70 emits air directly near the surgical incision 82, thetools held by the surgeon's hand 76 such as a scalpel 84. While theemitted air streamlines 88 may be unidirectional and essentially laminarnear the source, the flow tends to be reflected as shown by schematicstreamline 74 or deflected and diverted as shown by schematicstreamlines 78. Any irregularity of the surface can also affect thedirectionality of the flow as shown by streamlines 86, further away fromthe source. The reflected and deflected streams can change theirdirection in a way that would bring unpurified air to the incision. Inaddition the flow of air 88 can create an entrainment effect and dragunclean air shown schematically as streamlines 80 and 90 as wasdescribed in FIG. 3. The result is that while this device can reduceparticle load and the presence of bacteria from a surface, it is notpossible to completely eliminate contamination using this device.

FIG. 5 is a schematic drawing of an embodiment of the present invention.An aspect of the present invention is a pad 100, which can also bereferred to as a flexible sheet, which has at least one gas emittingfenestrations or nozzles 102 in at least one of its surfaces. In theembodiment of FIG. 5, the pad 100 has multiple fenestrations. The pad100 has flow-directing channels 104 and an inlet 106 that connects to ahose 108 that brings a flow of cleaned and conditioned gas from thepumping, filtering and conditioning source 110. In an embodiment of thepresent invention, the gas may comprise air that is cleaned bymechanical means, such as by filtration and/or centrifuge, and/or byphysical means, such as UV light. In further embodiments of the presentinvention, this gas may not comprise air, but, as understood by one ofskill in the art, the invention may utilize any type of suitable gas,including by not limited to, a mixture of 20% oxygen with 80% Helium(Heliox), and/or 20% oxygen with, for example, 80% Argon, or 100%oxygen. In addition, in an embodiment of the present invention, the gasmay be conditioned by heating or cooling or humidifying or drying it inthe pumping source 110.

FIG. 6 is a schematic diagram that details the construction of the gaspumping, filtering and conditioning source 110 in an embodiment of thepresent invention. In an embodiment of the present invention, a filter,including but not limited to an array of filters 112, cleans gas thatpasses through a UV light source 115 into the pump 114. The pump 114 maybe automatically or manually adjusted to provide sufficient flow for aparticular pad 100. The gas then may pass through a temperature andhumidity conditioning unit 116, where the gas is brought to a desiredtemperature and relative humidity level. The gas is then delivered intothe connector 118 to which the hose 108 (FIG. 5) is connected. Thepumping and conditioning unit may be equipped with internal shockobservers 113 and/or acoustical insulation walls 117 to keep the emittednoise level low.

In some embodiments of the present invention, the pump 114 mechanismincludes a particle counter comprised of at least one sensor, and a flowcontrol unit, integrated into the pump 114. The particle counter itselfis illustrated in FIG. 16, while the functionality is described in theworkflow 1500 of FIG. 15. Returning to FIG. 6, in some embodiments ofthe present invention, the particle counter, which is at least partiallyintegrated into the pump 114, and in some embodiments, is a cascadeimpactor, continuously samples, via the aforementioned one or moresensors, the airborne particles at a surgical site/preparation table andtriggers the flow control unit of the pump 114 to automatically adjustflow rate and pressure, accordingly. Thus, in order to effectively killbacteria in a cost efficient manner utilizing fluid dynamics, someembodiments of the present invention include a pump 114 that adjusts theflow (e.g., provides an adoptive flow), based on particle load, (sizeand/or number) in the field, as determined by one or more sensorscommunicatively coupled to the pump 114, where the one or more sensorsare located proximate to a surgical site/preparation table. Asaforementioned, FIG. 16. provides an illustration of the embodiment ofthe present invention with the particle counter specifically featured,while FIG. 15 is a workflow that provides an overview of thefunctionality of the particle detector aspects of embodiments of thepresent invention, including those integrated into the pump 114, thatenable the pump 114 to adjust flows based on particle load (e.g., sizeand number). In various embodiments of the present invention, the sizeand shape of the pad 100 may be adapted for the particular use. To thisend, FIG. 7 shows a schematic example of a pad 100 with an irregularshape 120. As in the pad 100 shown in FIG. 5, this pad 100 also hasfenestrations or nozzles in at least one of its surfaces 122 andchannels to facilitate internal gas flow 124 as well as a hose 128connected to the gas pumping member 110. The cut out part 126 is shownas an example of irregularity of the shape.

FIG. 8 depicts the use and orientation of an embodiment of the presentinvention during a particular surgical procedure. Specifically, FIG. 8shows a cut view of the pad 140 during operation. The figure shows a cutthrough the patient's legs 146 and 148 when placed on the mattress 142of an operating table 150. The pad 140 (a particle deflector pad) isshown as placed beneath on the patient's legs 146 and on top of thesterile drape 144 that covers the second, un-operated leg 148 and theentire table. The surgical incision 149 is shown schematically in thetop aspect of the limb. In this embodiment, the fenestrations andnozzles in the surface of the pad 140 are positioned to enable the gasflowing out of the pad to be directed essentially away from the operatedsurface, as shown by streamlines 152.

FIG. 9 is perspective view of the pad 160, in an embodiment of thepresent invention, placed beneath and around a thigh 162 of a patientundergoing surgery around the hip 168. As seen in this embodiment of thepresent invention, the pad 160 can be flexible in nature, to enable easeof manipulation and placement depending to best accommodate the needs inthe environment that it is being utilized. The fenestrations and nozzles164 of the pad 160 direct gas flow in streams 168, 170 and 172 thatengulf the limb and direct the gas flow in directions that areessentially perpendicular and away from the surgical field.

FIG. 10 is also a perspective view of an embodiment of the presentinvention in which a pad 180 is placed beneath an arm 182 placed on asurgical side-table 184. As seen in FIG. 10, air flow emitted from theupward and side folded surfaces of the Particle deflector pad 180 ispointed in streamlines 186 that schematically show the flow engulfingthe limb and flowing essentially perpendicular and away from it therebydeflecting any airborne particles that may be deposited on the surface.

Referring to FIG. 11A-11B, these figures depict an embodiment of thepresent invention that includes a pad for particle deflection where thepad includes an opening. Both FIGS. 11A-11B depict this opening in themiddle of the pad, however, these figures merely offer an illustrativeexample of one possible orientation for an opening as embodiments of thepresent invention may include an opening of any shape and positioned atany location within the perimeter of the pad.

Turning first to FIG. 11A, which is a schematic drawing of an embodimentof the invention where a pad 190 with its connecting hose 192 has anopening 194 in its surface. FIG. 11A illustrates that certainembodiments of the present invention are not placed under and beneaththe body part or the object that is to be kept particle-free andsterile, but can instead utilized by being placed on the body part orthe object. Utilizing this orientation, an operation or procedure can beperformed through the opening 194 in the pad. Flow of gas is emittedfrom the surface of the pad 190 facing away from the body part overwhich it is placed in an essentially perpendicular direction away fromthe surface.

FIG. 11B depicts the same embodiment shown in FIG. 11A from a differingperspective in order to illustrate how the fenestrations in the pad 190direct the flow in multiple angles including, but not limited to,directly perpendicular to the surface 200, diagonally directed insidefrom the edge of the pad's surface 202, and/or diagonally directedoutside around the perimeter of the pad 190, in order to deflectparticles.

FIG. 12 depicts an embodiment of the present invention where, to deflectparticles, the pad 210 is placed on a surface such as an instrumentstables 215 beneath at least one instrument tray 212 so that airborneparticles above the instruments that are to be handed to the surgeon byan assistant, nurse or technician 211 are maintained particle free andsterile throughout the duration of surgery. As seen in this figure, theflow 214 of clean and sterile gas upwards and perpendicular to theinstruments table 215 deflects the particles away from the areas thatare to remain sterile and prevents the particles from depositing on theinstruments.

As aforementioned, the embodiments of the pad in the present inventioninclude nozzles that are inserted in fenestrations. FIGS. 13A-13Cprovide various views of these aspects in certain embodiments of thepresent invention.

FIG. 13A depicts of a cut view of several nozzles 222 that are insertedthrough fenestrations in the surface 220 of the particle deflector pad226 so that flow of gas 224 can be directed out and away from thesurface 220 of the pad 226.

FIG. 13B is a perspective view of one nozzle 230 that can be securelyinserted into a fenestration in the surface of the pad. The nozzle 230can be inserted into a pad (not pictured) by utilizing various methodsknown to one of skill in the art, including by not limited to, utilizingdiagonally shaped pedicles 232 that can be flexibly forced through thesurface of the pad (not pictured). In an embodiment of the presentinvention the opening 234 is designed (the parameters of the opening areselected) such that gas may be emitted through the opening 234 atpredetermined pressure-flow relationship with a predetermined fanning ofthe flow.

FIG. 13C further illustrates the flow through a nozzle (FIG. 13B). FIG.13C depicts a cut view of a nozzle 240 inserted into an opening 230 inan upper surface 242 of a particle deflection pad 260, in an embodimentof the present invention. In an embodiment of the present invention, aninner space of the pad bounded by the top surface 242 and a bottomsurface 246 are connected at their respective perimeters. This innerspace formed by the connection may be filled with a variety ofsubstances, including but not limited to, gas (including gas alone),and/or a compressible porous medium 244. The porous medium may include,but in not limited to an open-cell foam or fibers. An advantage of anembodiment of the present invention that includes a compressible porousmedium 244 in that even when a load is placed on top of the pad 260, gascan flow from one part of the pad to another with little or noimpediment.

The shape of a nozzle (through an opening) may differ in embodiments ofthe present invention. Certain embodiments of the present invention mayinclude a nozzle that is cylindrical, as illustrated in FIG. 13A. FIG.13C, meanwhile, illustrates an embodiment of the present invention wherethis opening is shaped in an hourglass shape to facilitate diffusion ofthe gas flow in streamlines, as shown schematically by the arrows 254 asthey exit the nozzle. In an embodiment of the present invention, anoptional wedge 250 can be used to further shape and control the gas flowthrough some or all of the nozzles. In this FIG. 13C the diameterindicated by “a” is the diameter of the gas inlet into the nozzle, thediameter indicated by “b” is the outer diameter of the cone-shaped flowdivider at the gas inlet inot the nozzle, and the diameter indicated by“c” is the diameter of the narrowest segment of the hourglass-shapednozzle. The ratio of b/a may be selected between 0.3 to 0.7 and theratio of c/a may be selected between 0.15 to 0.5.

FIGS. 14A-14B depict certain aspects of a process of manufacturing aparticle deflection pad, as illustrated, e.g., in FIGS. 5-12, where thenozzles are made as an integral part of the surface of the Particledeflector pad by 3D printing of elastomer material or by injectionmolding of the surface with elastic, antistatic and biocompatiblematerial. The method of manufacturing such surface which includes thenozzles as an integral part of the sheet includes creation of a moldthat is the negative of the shape of the surface with its plurality ofnozzles that are designed and spaced according to the needed flowcharacteristics as outlined previously. Such mold is then used tomanufacture sheets of various sizes and shapes as required for variousapplications of this invention. An alternative method of manufacturingemploys the method of 3 dimensional (3D) printing using flexibleplastics as the printing material. While the mold method requires morecostly setting up costs, it allows for inexpensive volume manufacturing.The advantage of the 3D printing method is that it can easily be adoptedto manufacture pads of various and irregular shape and sizes.

FIG. 15 is a workflow 1500 that illustrates certain aspects offunctionalities provided in part by the pump (e.g., FIG. 6, 114) in someembodiments of the present invention. Specifically, the pump mechanismincludes, in some embodiments of the present invention, a particlecounter comprised of at least one sensor, and a flow control unit, thelatter being integrated into the pump (e.g., FIG. 6, 114). Referring toFIG. 15, in some embodiments of the present invention, sensors of theparticle counter 1520 sense airborne particle levels in an operatingroom (OR) (e.g., at a surgical site, on an operating table, etc.), basedon placement of the sensors of the particle counter 1520. The sensorscan be active and/or passive sensors and thus, can either activelyprovide the flow control unit 1530 with the particle levels (e.g.,particle load, including size and/or number and/or number per unit oftime) and/or the flow control unit 1530 can poll the sensors of theparticle counter 1520, to determine the particle levels. In someembodiments of the present invention, the flow control unit 1530 can beconfigured to determine the particle levels based on data provided bythe sensors of the particle counter 1520, over a pre-defined period oftime. In some embodiments of the present invention, the flow controlunit 1530 determines particle levels continuously. Based on the particlelevels determined by the flow control unit 1530, based on the sensors ofthe particle counter 1520, the flow control unit 1530 automaticallyadjusts the upstream velocity from the pad 1540. Hence, the airborneparticles at a surgical site/preparation table, as monitored by thesensors of the particle counter 1520, trigger the flow control unit 1530of the pump to automatically adjust flow rate and/or pressure. Theautomatic flow rate and/or pressure adjustment adjusts the upstreamvelocity from pad 1540. In some embodiments of the present invention,the magnitude of the particle load servo controls the gas flow into thechannel in the pad.

Referring to FIG. 16, as discussed earlier, in embodiments of thepresent invention, a particle counter 1640, which is comprised of a oneor more sensors 1620, and a flow control unit 1630, continuouslysamples, via the aforementioned one or more sensors 1620, the airborneparticles at a surgical site/preparation table 1605 and triggers theflow control unit 1630 of the pump to automatically adjust flow rateand/or pressure, based on the particle levels (e.g., particle load,including size and/or number and/or number per unit of time) sensed bythe one or more sensors and obtained by the communicatively coupled flowcontrol unit 1630. In some embodiments of the present inventions, theone or more sensors are placed proximate to a top surface of the pad1660. The flow control unit 1630 may comprise one or more processor,communicatively coupled to the one or more sensors of the particlecounter 1640, and thus, able to receive data (counts, particle load,particle size, etc.) from the one or more sensors. Based on obtainingthis data, the flow control unit 1630 adjusts the flow rate and pressure(e.g., upstream velocity 1650 from the pad 1660). In some embodiments ofthe present invention, the flow control unit 1630 may include amicroprocessor to make automatic adjustments based on particle load. Asincreased particle load could cause the flow control unit 1630 toincrease the upstream velocity 1650, in order to avoid an accumulationof particles on the pad 1660 or at the surgical site/preparation table1605, in general. Thus, adjusting the velocity based on the particlesize and/or load maintains a surgical environment that is sanitary.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention. Asused herein, the singular forms “a”, “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprises”and/or “comprising”, when used in this specification, specify thepresence of stated features, integers, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, integers, steps, operations, elements,components and/or groups thereof.

The corresponding structures, materials, acts, and equivalents of allmeans or steps plus function elements in the descriptions below, if any,are intended to include any structure, material, or act for performingthe function in combination with other elements as specifically noted.The description of the technique has been presented for purposes ofillustration and description, but is not intended to be exhaustive orlimited to the invention in the form disclosed. Many modifications andvariations will be apparent to those of ordinary skill in the artwithout departing from the scope and spirit of the invention. Theembodiment was chosen and described in order to best explain theprinciples of the invention and the practical application, and to enableothers of ordinary skill in the art to understand the invention forvarious embodiments with various modifications as are suited to theparticular uses contemplated.

An aspect of an embodiment of the present invention is an apparatus fordeflecting airborne particles from a surface that is exposed to ambientair, but needs to be maintained clean and free of organic and inorganicparticulate matter comprising a pad in a shape suitable to surround thesurface from two or more directions emitting purified air flow through aplurality of fenestrations or nozzles in its surface in a direction thatis essentially perpendicular and away from the surface in a flow ratethat is sufficient to deflect the particles of sizes and densities thatprevail in the ambient air.

In an embodiment of the present invention, the aforementioned pad iseither rectangular or has an irregular shape.

In an embodiment of the present invention, the pad has an opening in atleast one of its surfaces.

When utilized to deflect particles during a procedure, in an embodimentof the present invention, the pad may be placed under the member that isto be maintained clean and free of particulate matter. This placement isillustrated in FIGS. 8-10.

When utilized to deflect particles during a procedure, in an embodimentof the present invention, the pad may be placed surrounding a surfacethat needs to be maintained clean and free of particulate matter withthe opening exposing a work surface. This placement is illustrated inFIG. 11.

In an embodiment of the present invention, to deflect particles during aprocedure, the pad described is placed on a surface under the objectsthat need to be maintained clean and free of particulate matter. Thisplacement is illustrated in FIG. 12.

In an embodiment of the present invention, in the aforementionedapparatus for deflecting airborne particles from a surface that isexposed to ambient air, at least one of the surfaces of the pad hasfenestrations of diameters in the range of 0.05 to 0.5 cm.

In an embodiment of the present invention, in the aforementionedapparatus for deflecting airborne particles from a surface that isexposed to ambient air, there are a plurality of flow-emitting nozzlesembedded or inserted in the at least one surface of the pad.

In an embodiment of the present invention, in the aforementionedapparatus for deflecting airborne particles from a surface that isexposed to ambient air the density of fenestrations or flow emittingnozzles in at least one surface is in the range of 10 to 100 for eachsquare decimeter of the surface.

In an embodiment of the present invention, in the aforementionedapparatus for deflecting airborne particles from a surface that isexposed to ambient air, the cross section of opening in each individualnozzle is cylindrical. This aspect of certain embodiments of the presentinvention is illustrated in FIG. 13A.

In an embodiment of the present invention, in the aforementionedapparatus for deflecting airborne particles from a surface that isexposed to ambient air, the surface of the pad described earliercontains openings and the cross section of the opening in eachindividual nozzle is tapered. One example of how the nozzle could betapered is illustrated in FIG. 13C.

In an embodiment of the present invention, in the aforementionedapparatus for deflecting airborne particles from a surface that isexposed to ambient air, the surface of the pad described earliercontains openings where the cross section of the opening in eachindividual nozzle combines cylindrical and tapered shapes. Oneembodiments that includes this aspect is illustrated by FIGS. 14A-14B.

In an embodiment of the present invention, in the aforementionedapparatus for deflecting airborne particles from a surface that isexposed to ambient air, the surface of the pad described earlier (andcharacterized as a particle reflector pad) is supplied with essentiallyparticle-free sterile air at a predetermined flow rate. In an embodimentof the present invention, this flow rate is equal to or exceeds 1.8liter per minutes per each 100 square cm of pad surface area.

In an embodiment of the present invention, in the aforementionedapparatus for deflecting airborne particles from a surface that isexposed to ambient air, the surface of the pad described earlier issupplied with essentially particle-free sterile air at a controlledtemperature.

In an embodiment of the present invention, in the aforementionedapparatus for deflecting airborne particles from a surface that isexposed to ambient air, the surface of the pad described earlier, the(particle deflecting) pad is supplied with essentially particle-freesterile air at a controlled humidity.

In an embodiment of the present invention, in the aforementionedapparatus for deflecting airborne particles from a surface that isexposed to ambient air, the aforementioned pad for deflecting particlesis supplied with essentially particle-free sterile gas of a specific gascomposition that is different from the composition of ambient air.

In an embodiment of the present invention, in the aforementionedapparatus for deflecting airborne particles from a surface that isexposed to ambient air, the aforementioned pad for deflecting particlesis supplied with essentially particle-free sterile gas of specific gascomposition. I an embodiment of the present invention, an example of onecomposition is pure Oxygen.

In an embodiment of the present invention, in the aforementionedapparatus for deflecting airborne particles from a surface that isexposed to ambient air, the aforementioned pad for deflecting particlesis supplied with essentially particle-free sterile gas of specific gascomposition. One example of a specific composition is 20% Oxygen, 80%Helium.

An aspect of an embodiment of the present invention is a method fordeflecting airborne particles from a surface that is exposed to ambientair, but needs to be maintained clean and free of organic and inorganicparticulate matter. The method includes utilizing a pad in a shapesuitable to surround the surface from two or more directions and the pademits purified air flow through a plurality of fenestrations or nozzlesin its surface in a direction that is essentially perpendicular and awayfrom the surface in a flow rate that is sufficient to deflect theparticles of sizes and densities that prevail in the ambient air.

In an embodiment of the present invention, the method includesdeflecting particles from a surface by emitting an essentiallyperpendicular to the surface flow of particle-free gas from a padsurrounding the surface from at least two sides. For example, in thisembodiment of the present invention, the flow-emitting pad is placed sothat gas flows from at least two sides of the surface that is maintainedparticle-free.

In an embodiment of the present invention the method includes utilizinga pad where the flow rate of the emitted gas exceeds the flow needed toovercome the gravitational force of particles that are 20 micron inaerodynamic diameter.

In an embodiment of the present invention the method includes utilizinga pad where the gas flow is at a controlled temperature, humidity and/orgas composition.

Some embodiments of the present invention include a device that includesa pad with a sheet of flexible material comprising a top surface and abottom surface and an area in-between, the top surface comprising ahole. The pad also includes a gas-flow directing channel formed in aportion of the area on a horizontal plane parallel to the top surface,where the gas-flow directing channel accommodates gas moving through thegas-flow directing channel, where the gas-flow directing channel isdefined by a cylindrical channel in the flexible material in the portionof the area. The pad include an opening formed in the flexible materialdefining the gas-flow directing channel, the opening situated adjacentto the hole. The pad includes a nozzle formed in the opening and in thehole, where the nozzle directs the gas from the gas-flow directingchannel in a direction predominantly perpendicular to the top surface ofthe pad, to prevent sedimentation of airborne particles on the topsurface. The pad also includes an inlet in a second portion of the areato accommodate a hose, where attaching the hose to the inlet providesthe gas to the gas-flow directing channel in the pad. In someembodiments of the present invention, the device may also include a hosecoupled to the inlet and a conditioning source coupled to the hose,where the conditioning source provides gas to the hose.

In some embodiments of the present invention, the conditioning systemincludes a filter comprising one or more openings through which the gaspasses from outside of the conditioning source to inside of theconditioning source. This system also includes a UV light source locatedinside the conditioning source at a location proximate to the filter,where the UV light source obtains the gas subsequent to the gas passingthrough the filter. The system also includes a temperature and humidityconditioning unit, where the temperature and humidity conditioning unitreceives the gas subsequent to exposure of the gas to the UV lightsource, where the temperature and humidity conditioning unit adjusts oneor more of the temperature and the humidity of the gas and a connectorcoupled to the temperature and humidity conditioning unit, where theinlet receives the gas from the temperature and humidity conditioningunit and provides the gas to the hose. The conditioning source in someembodiments is a mechanical cleaning means coupled to the hose.

In some embodiments of the present invention, the pad portion of thedevice includes the bottom surface comprising a second hole, a secondopening formed in the flexible material defining the gas-flow directingchannel, the second opening situated adjacent to the second hole, and anozzle formed in the second opening and the second hole, where thenozzle directs the gas from the gas-flow directing channel in adirection predominantly perpendicular to the bottom surface of the pad,to prevent sedimentation of airborne particles on the bottom surface.

In some embodiments of the present invention, the device includes a paswith a plurality of holes in the top surface. The pad also include aplurality of gas-flow directing channels in the area, where eachgas-flow directing channel of the plurality of gas-flow directingchannels is defined by a cylindrical channel in the flexible material inthe area, a plurality of additional openings formed in the flexiblematerial, each opening of the plurality of additional openings formed inthe flexible material retaining the gas in the gas-flow directingchannel formed adjacent to a respective hole in the top surface of theplurality of openings in the top surface, and a plurality of nozzles,where each nozzle of the plurality of nozzles is formed in each openingand the respective hole such that each nozzle of the plurality ofnozzles emits a given portion of gas from the gas-flow directingchannel, in a direction predominantly perpendicular to the top surfaceof the pad. In some embodiments of the present invention, the pad is anirregular shape.

In some embodiments of the present invention, the nozzle was formed asan integral part of the sheet.

Some embodiments of the present invention include a device that includesa pad comprised of a flexible material with a top surface and a bottomsurface and two side surfaces, where the top surface is parallel to thebottom surface, the top surface comprising a plurality of openings,where each opening terminates at location in a channel formed in theflexible material between the top surface and the bottom surface, wherethe pad further comprises an inlet in a side surface, the inletconfigured to accept a hose, and a plurality of nozzles, where eachnozzle is formed in an opening of the plurality of openings. The devicemay also include a hose coupled to the inlet and a conditioning sourcecoupled to the hose, where the conditioning source provides gas to thehose.

In some embodiments of the present invention, each nozzle of theplurality of nozzles comprises an outlet for directing a Jetstream ofgas from inside the channel in essentially a perpendicular directionaway from the top surface of the pad. These nozzles may be formed as anintegral part of the openings.

Embodiments of the present invention include methods for preventingsedimentation of airborne particles on a surface. The methods includesplacing a pad on the surface, where the pad includes a sheet of flexiblematerial comprising a top surface and a bottom surface and an areain-between, the top surface comprising a hole, a gas-flow directingchannel formed in a portion of the area on a horizontal plane parallelto the top surface, wherein the gas-flow directing channel accommodatesgas moving through the gas-flow directing channel, wherein the gas-flowdirecting channel is defined by a cylindrical channel in the flexiblematerial in the portion of the area, an opening formed in the flexiblematerial defining the gas-flow directing channel, the opening situatedadjacent to the hole, a nozzle formed in the opening and in the hole,wherein the nozzle directs the gas from the gas-flow directing channelin a direction predominantly perpendicular to the top surface of thepad, to prevent sedimentation of airborne particles on the top surface,and an inlet in a second portion of the area to accommodate a hose,wherein attaching the hose to the inlet provides the gas to the gas-flowdirecting channel in the pad. The method also includes coupling a hoseto the inlet, wherein the hose is coupled to a conditioning source,wherein the conditioning source provides gas to the hose, and conductingan activity in a vicinity of the pad, wherein the surface remainssterile. The method may also include maintaining the object on theportion of the top surface of the pad during the activity.

In an embodiment of the present invention, the surface includes anoperating table and the activity includes a surgical procedure. Themethod may also include placing an object of the activity on a portionof the top surface of the pad.

1. A device comprising: a pad comprising: a sheet of flexible materialcomprising a top surface and a bottom surface and an area in-between,the top surface comprising a hole; a gas-flow directing channel formedin a portion of the area on a horizontal plane parallel to the topsurface, wherein the gas-flow directing channel accommodates gas movingthrough the gas-flow directing channel, wherein the gas-flow directingchannel is defined by a cylindrical channel in the flexible material inthe portion of the area; an opening formed in the flexible materialdefining the gas-flow directing channel, the opening situated adjacentto the hole; a nozzle formed in the opening and in the hole, wherein thenozzle directs the gas from the gas-flow directing channel in adirection predominantly perpendicular to the top surface of the pad, toprevent sedimentation of airborne particles on the top surface; an inletin a second portion of the area to accommodate a hose, wherein attachingthe hose to the inlet provides the gas to the gas-flow directing channelin the pad; and a particle counter comprising one or more sensorspositioned proximate to the top surface, for measuring the particleloads above the pad, wherein a magnitude of a measured particle loadservo controls a flow of the gas into the gas-flow directing channel. 2.The device of claim 1, further comprising: a hose coupled to the inlet;and a conditioning source coupled to the hose, wherein the conditioningsource provides gas to the hose.
 3. The device of claim 2, theconditioning source further comprising: a filter comprising one or moreopenings through which the gas passes from outside of the conditioningsource to inside of the conditioning source; a UV light source locatedinside the conditioning source at a location proximate to the filter,wherein the UV light source obtains the gas subsequent to the gaspassing through the filter; a temperature and humidity conditioningunit, wherein the temperature and humidity conditioning unit receivesthe gas subsequent to exposure of the gas to the UV light source,wherein the temperature and humidity conditioning unit adjusts one ormore of the temperature and the humidity of the gas; a connector coupledto the temperature and humidity conditioning unit, wherein the inletreceives the gas from the temperature and humidity conditioning unit andprovides the gas to the hose; and a flow control unit communicativelycoupled to the particle counter, wherein the flow control unitautomatically adjusts the flow of the gas into the gas-flow directingchannel, based on the magnitude of the measured particle loads.
 3. Thedevice of claim 2, the conditioning source further comprising: amechanical cleaning means coupled to the hose.
 4. The device of claim 1,the pad further comprising: the bottom surface comprising a second hole;a second opening formed in the flexible material defining the gas-flowdirecting channel, the second opening situated adjacent to the secondhole; and a nozzle formed in the second opening and the second hole,wherein the nozzle directs the gas from the gas-flow directing channelin a direction predominantly perpendicular to the bottom surface of thepad, to prevent sedimentation of airborne particles on the bottomsurface.
 5. The device of claim 1, the pad further comprising: aplurality of holes in the top surface; a plurality of gas-flow directingchannels in the area, wherein each gas-flow directing channel of theplurality of gas-flow directing channels is defined by a cylindricalchannel in the flexible material in the area; a plurality of additionalopenings formed in the flexible material, each opening of the pluralityof additional openings formed in the flexible material retaining the gasin the gas-flow directing channel formed adjacent to a respective holein the top surface of the plurality of openings in the top surface; anda plurality of nozzles, wherein each nozzle of the plurality of nozzlesis formed in each opening and the respective hole such that each nozzleof the plurality of nozzles emits a given portion of gas from thegas-flow directing channel, in a direction predominantly perpendicularto the top surface of the pad.
 6. The device of claim 1, wherein the padis an irregular shape.
 7. The device of claim 1, wherein the nozzle wasformed as an integral part of the sheet.
 8. A device comprising: a padcomprised of a flexible material with a top surface and a bottom surfaceand two side surfaces, wherein the top surface is parallel to the bottomsurface, the top surface comprising a plurality of openings, whereineach opening terminates at location in a channel formed in the flexiblematerial between the top surface and the bottom surface, wherein the padfurther comprises an inlet in a side surface, the inlet configured toaccept a hose; a hose coupled to the inlet; a plurality of nozzles,wherein each nozzle is formed in an opening of the plurality ofopenings; a particle counter comprising one or more sensors positionedproximate to the top surface, for measuring the particle loads above thepad, wherein a magnitude of a measured particle load servo controls aflow of gas into the channel, via the hose; and a flow control unitcommunicatively coupled to the particle counter, wherein the flowcontrol unit automatically adjusts the flow of the gas into the channel,via the hose, based on the magnitude of the measured particle loads. 9.The device of claim 8, further comprising: a conditioning source coupledto the hose, wherein the conditioning source provides gas to the hose.10. The device of claim 9, wherein each nozzle of the plurality ofnozzles comprises an outlet for directing a Jetstream of gas from insidethe channel in essentially a perpendicular direction away from the topsurface of the pad.
 11. The device of claim 9, the conditioning sourcecomprising: the flow control unit; a filter comprising one or moreopenings through which the gas passes from outside of the conditioningsource to inside of the conditioning source; a UV light source locatedinside the conditioning source at a location proximate to the filter,wherein the UV light source obtains the gas subsequent to the gaspassing through the filter; a temperature and humidity conditioningunit, wherein the temperature and humidity conditioning unit receivesthe gas subsequent to exposure of the gas to the UV light source,wherein the temperature and humidity conditioning unit adjusts one ormore of the temperature and the humidity of the gas; and a connectorcoupled to the temperature and humidity conditioning unit, wherein theinlet receives the gas from the temperature and humidity conditioningunit and provides the gas to the hose.
 12. The device of claim 8,wherein the nozzle are formed as an integral part of the openings.
 13. Amethod for preventing sedimentation of airborne particles on a surface,the method comprising: placing a pad on the surface, the pad comprising:a sheet of flexible material comprising a top surface and a bottomsurface and an area inbetween, the top surface comprising a hole; agas-flow directing channel formed in a portion of the area on ahorizontal plane parallel to the top surface, wherein the gas-flowdirecting channel accommodates gas moving through the gas-flow directingchannel, wherein the gas-flow directing channel is defined by acylindrical channel in the flexible material in the portion of the area;an opening formed in the flexible material defining the gas-flowdirecting channel, the opening situated adjacent to the hole; a nozzleformed in the opening and in the hole, wherein the nozzle directs thegas from the gas-flow directing channel in a direction predominantlyperpendicular to the top surface of the pad, to prevent sedimentation ofairborne particles on the top surface; and an inlet in a second portionof the area to accommodate a hose, wherein attaching the hose to theinlet provides the gas to the gas-flow directing channel in the pad;orienting a particle counter comprising one or more sensors positionedproximate to the top surface, for measuring the particle loads above thepad, wherein a magnitude of a measured particle load servo controls aflow of the gas into the gas-flow directing channel; coupling a hose tothe inlet, wherein the hose is coupled to a conditioning source, whereinthe conditioning source provides gas to the hose; and conducting anactivity in a vicinity of the pad, wherein the surface remains sterile.14. The method of claim 13, wherein the conditioning source comprises: afilter comprising one or more openings through which the gas passes fromoutside of the conditioning source to inside of the conditioning source;a UV light source located inside the conditioning source at a locationproximate to the filter, wherein the UV light source obtains the gassubsequent to the gas passing through the filter; a temperature andhumidity conditioning unit, wherein the temperature and humidityconditioning unit receives the gas subsequent to exposure of the gas tothe UV light source, wherein the temperature and humidity conditioningunit adjusts one or more of the temperature and the humidity of the gas;a connector coupled to the temperature and humidity conditioning unit,wherein the inlet receives the gas from the temperature and humidityconditioning unit and provides the gas to the hose; and a flow controlunit communicatively coupled to the particle counter, wherein the flowcontrol unit automatically adjusts the flow of the gas into the gas-flowdirecting channel, based on the magnitude of the measured particleloads.
 15. The method of claim 13, wherein the gas comprises a mixtureof 20% oxygen with 80% Helium.
 16. The method of claim 13, wherein thegas comprises a mixture of 20% oxygen with 80% Argon.
 17. The method ofclaim 13, wherein the gas comprises approximately 100% oxygen.
 18. Themethod of claim 13, wherein the surface comprises an operating table andthe activity comprises a surgical procedure.
 19. The method of claim 13,further comprising: placing an object of the activity on a portion ofthe top surface of the pad.
 20. The method of claim 19, furthercomprising: maintaining the object on the portion of the top surface ofthe pad during the activity.